About Caps Medical
CAPS Medical has developed a highly selective and minimally invasive Non-thermal Atmospheric Plasma (NTAP) device able to painlessly treat a wide range of solid tumors without impacting surrounding tissue.
Working at CAPS Medical will enable you to grow your career and join a team of talented people, committed to making a difference in the way cancer is treated.
Objective:
CAPS medical is seeking a talented and experienced VP of Clinical Affairs with a focus on research and development of complex multidisciplinary devices, to join our growing team and participate in the development of Non Thermal Plasma technology, with role growth opportunities.
In this role you will lead development and execution of the company’s clinical strategy and clinical goals and execution of clinical studies. To take part in research and definition of clinical applications support and involvement in R&D effort.
Main Responsibilities:
- Lead the development and implementation of the clinical strategy for NTAP technology.
- Plan and oversee the execution of clinical studies, including study design, protocol development, data management, and analysis.
- Establish clinical operation infrastructure for US and EU clinical studies
- Collaborate with cross-functional teams, including R&D, Regulatory Affairs, quality, and marketing to ensure successful product development and commercialization.
- Build and manage relationships with key stakeholders, including KOLs, investigators, and regulatory agencies.
- Develop and manage clinical budgets, timelines, and project plans.
- Ensure that all clinical activities and clinical investigation are conducted in full compliance with applicable standards and regulations, and company policies.
- Develop and maintain clinical SOPs
Requirements:
- Advanced degree (MSc, MD, PhD, or equivalent) in a relevant medical or scientific field.
- 10 years experience in hands on clinical investigation, with a focus on complex medical devices and international clinical studies, in support of regulatory submissions including FDA, CE, and other.
- Experience in establishing clinical operations in US and Europe
- At least 5 years of hands on clinical experience in medical device startup company.
- Excellent project management and leadership skills.
- Strong communication, collaboration, and interpersonal skills.
- Ability to work independently and as part of a team in a fast-paced, dynamic environment.
- Willingness to travel abroad according to the project needs.